FDA WARNING_LETTER - Derby Paradise, Inc. - March 17, 2017

On March 2 and 17, 2017, the FDA inspected Derby Paradise, Inc., a seafood importer in Rosedale, NY, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). Specifically, the firm failed to implement an affirmative step to ensure imported canned tuna fish in sunflower oil with pepper was processed in accordance with seafood HACCP regulations, as required by 21 CFR 123.12(a)(2)(ii).

This violation renders the canned tuna fish adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)), as it was prepared, packed, or held under insanitary conditions potentially injurious to health. The FDA warns that failure to correct these violations may result in refusal of admission for imported products, detention without physical examination, seizure of products, and/or injunctions.

Derby Paradise, Inc. must respond in writing within fifteen working days, outlining specific corrective actions, including documentation of corrected HACCP and importer verification records, and evidence of affirmative steps. Failure to complete corrections requires an explanation and timeline. The FDA also noted that re-inspection fees may be assessed to cover costs related to verifying compliance. The letter emphasizes the firm's responsibility to ensure full compliance with the Act and